One of the common concerns in cardiac catheterization and related interventions is the problem of bleeding after catheterization of a vessel. This well known and familiar problem may even need corrective surgery in extreme cases.
A commonly used method of preventing such complication is quite primitive, and may be ineffective in some instances. That method is to position a sand bag in the area over a pressure bandage. In general, it may be considered a rather crude and uncomfortable method since, 1) it does not apply an appropriate amount of pressure all the time, 2) the sand bag may slide and/or fall, 3) the patient must be kept practically motionless to avoid dislocation of the sand bag, and 4) the patient is usually told not to raise the head over 15 degrees. Insofar as the applicant is aware, no other method has replaced the sand bag to any significant degree.
This problem has led to the applicant's creation of a much better alternative, which the applicant has named the D. Device. This device affords much easier use, gives much better pressure control, and is more comfortable for the patient. Not only can the patient move more, but it is believed that he/she may be discharged earlier from the hospital.
Briefly, the device is designed to prevent bleeding after catheterization of a groin vessel in connection with any of a number of different interventions, such as angiography for the heart, brain, arteries, etc., during which a vessel, such as an artery, has to be entered for diagnostic or treatment purposes. Naturally, the resulting wound has tendency to bleed.
The device comprises a main wrap, made preferably from tough synthetic fabric, which wraps around both the lower abdomen and the upper thighs to give support for the application of pressure to the groin by a specially shaped inflatable balloon contained within the wrap. The pressure inside the balloon can be monitored by a gauge, which can also have a safety alarm to indicate if the pressure inside the balloon drops. Another wrap, made preferably from a thin layer of non-irritating, soft, disposable material matching the shape of the main wrap may cover the skin under the main wrap to prevent contamination. Means are also provided so that bleeding which may occur after the device has been placed on the person can be seen by an observer.
Lately I have noticed that the anxiety of patients from bleeding after catheterization is real and well founded; they get very concerned about the development of bleeding and even minimal expansion in their arteries. I have heard from my own patients about their fear that with movement, their artery may open and bleed. These reactions, as well as worries of people with hernia, made me believe that there is a need for better protection and assurance of patients from bleeding and complications after cardiac catheterization and related interventions. This thought, as well as my own concern about patients' well being, have resulted in a modification and improvement in my previous device. This improvement, which I call D.Device 2, will be used to protect a patient when he or she is ready to be discharged from the hospital or cardiac catheterization lab clinic. It also provides peace of mind to patients, their relatives, and the physician. Also, the anxiety and concern of patients with hernia have resulted in modification of this unit to allow it to be very beneficial in patients with hernia or similar problems.
D.Device 2 comprises a unit that has a pressurized balloon that is held in place by straps, wraps, or shorts, to prevent bleeding and related complications in the groin area after cardiac catheterization or similar procedures. The unit is also very beneficial in patients with hernia or similar problems by applying pressure in front of a hernia to prevent its expansion related problems.
This unit comprises one or two balloons, each having a shape similar, but not identical, to a half moon. These balloons, or their covers, have lines, areas or patches of adhesive film or Velcro.TM. on the surface that allow their position to be modified and adjusted for best placement in the beginning and later as many times as necessary. These balloons are held in place by use of a support system that consists of straps, wraps, or special shorts that allow the pressure to be built up and kept in the groin area for prevention of bleeding.
The use of two balloons, as well as special shapes of the support systems, gives a great advantage over my previous models by allowing a patient to bend his or her leg easily and to sit in a chair, which is going to occur most of the time during transportation by car, etc. The unit may also have another balloon to go over these two balloons and make delivery of a greater pressure in the area possible when the patient lays on the bed. This unit will provide the protection to the area after cardiac catheterization and related procedures, and I believe will give a great deal of peace of mind to the patients and will make their anxiety disappear. A newer means for finding bleeding after catheterization in the area is also mentioned, involving use of an electric system connected to an alarm system.
In my further improvement invention, which I call D.Device 3, the unit comprises an inner unit made from combinations of soft absorbent layer such as a cotton fabric and an elastic, stretchable, non-irritant cover, such as a latex layer. These are connected to each other either by spots or layers of glue or by being sewed or by similar means. The outer layer of the latex will allow layers of non-stretchable material to be glued on it to cause its length to be controlled. This inner unit will be used to hold a balloon over an opening in the skin and then to allow a non-stretchable outer unit to be applied over it to hold the inner unit in place safely and allow the build up of the pressure inside the balloon. The amount of pressure will be observed by a gauge and alarm to prevent under- or over-pressurization. One other advantage of this unit is to allow the medical staff to choose different size balloons to match the size of different patients; different covers will give the same option as well, so that overall this unit will be of tremendous help in prevention of bleeding and of great help in such patients. This unit by its mere construction will provide physical and mental security to patients and allow them to feel secure and comfortable. I believe that this unit will also help these patients to be released faster and safer from the hospital after those procedures. The unit with only minimal modification can also be very useful in patients with inguinal hernia, or after hernia operations and certain surgeries.
Further detail of the invention, and other features, will be seen as the description proceeds.